05 Dec CHRONIC SPONTANEOUS URTICARIA: Ongoing Study Compares Efficacy REMIBRUTINIB VERSUS DUPILUMAB
MedicalResearch.com Interview with:
Dr. Mosnaim
Dr. Giselle Mosnaim MD MS FACAAI
Allergist
Division of Allergy and Immunology
Department of Medicine
Northshore University Health System
REMIX-1/-2 Investigator
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Chronic spontaneous urticaria is a debilitating condition significantly affecting patient quality of life and is characterized by the presence of itch, hives, and/or angioedema (swelling) lasting for greater than 6 weeks, without identifiable trigger. Second-generation H1-antihistamines at standard doses are recommended as first-line treatment for patients with chronic spontaneous urticaria, and can be up-dosed to 4 times the standard dose. However, over 50% of patients continue to have symptoms despite this therapy. Both Remibrutinib and Dupilumab are FDA-approved for the treatment of chronic spontaneous urticaria in adult patients (Remibrutinib ≥ 18 years old and Dupilumab ≥ 12 years old) who remain symptomatic despite second-generation H1-antihistamine treatment.
The RECLAIM study is an ongoing head-to-head randomized controlled trial comparing the efficacy of Remibrutinib, an oral Bruton’s tyrosine kinase inhibitor, and Dupilumab, an injectable anti-interleukin-4 and anti-interleukin-13 inhibitor, at early timepoints (4 weeks and earlier) when administered as an add-on therapy in adults with moderate to severe chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines.
MedicalResearch.com: What should readers take away from your report?
Response: Given the chronic debilitating nature of chronic spontaneous urticaria, patients with this condition often seek fast relief from itch, hives and/or swelling. This head-to-head trial will evaluate the efficacy of Remibrutinib and Dupilumab at early timepoints (4 weeks and earlier), which is a patient-important outcome.
MedicalResearch.com: What recommendations do you have for future research as a results of this study?
Response: This study is enrolling up to 30% of participants with prior exposure to anti-Immunoglobulin E biologics for chronic spontaneous urticaria. It will be important to examine change from baseline in itch, hives, and swelling scores in anti-Immunoglobulin E naïve and anti-Immunoglobulin E experienced patients across the patients randomized to Remibrutinib and Dupilumab.
Disclosures: Dr. Mosnaim receives current research grant support from Areteia, Astra Zeneca, Celldex, GlaxoSmithKline, Genentech, Incyte, Merck, Novartis, Sanofi, Regeneron and Teva; and receives consulting, advisory board, and/or speaking fees from Abbott, Amgen, Astra Zeneca, Chiesi, Eli Lilly, Genentech, GlaxoSmithKline, Jasper, Novartis, Sanofi, Regeneron, and Teva.
Citation:
EFFICACY OF REMIBRUTINIB VERSUS DUPILUMAB IN CHRONIC SPONTANEOUS URTICARIA: US PHASE 3B STUDY DESIGN (RECLAIM)
Presented at ACAAI Meeting November 2025
https://college.acaai.org/wp-content/uploads/2025/11/ACAAI_ProgramGuide_2025_FINAL.pdf
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Last Updated on December 6, 2025 by Marie Benz MD FAAD